Product code GTR— Microbiology
ANTI-DNASE B REAGENT SYSTEM
- Classification name
- Antideoxyribonuclease, Streptococcus Spp.
- Device class
- Class 1
- Regulation
- 21 CFR 866.3720
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code GTR
FDA has cleared device under product code GTR, all in 1979, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code GTR
Recent clearances under product code GTR
Data sourced from openFDA. This site is unofficial and independent of the FDA.